Endoscopic stitching devices

ABSTRACT

The present disclosure relates to devices, systems and methods for endoscopic suturing or stitching through an access tube or the like. An endoscopic stitching device is provided and includes a handle assembly; an elongate shaft supported by and extending from the handle assembly; and an end effector supported on a distal end of the elongate shaft. The end effector includes a neck assembly configured and adapted for articulation in one direction between a substantially linear configuration and an off-axis configuration, and a pair of juxtaposed jaws pivotally associated with one another. Each jaw defines a suture needle receiving recess formed in a tissue contacting surface thereof.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a Continuation Application which claims thebenefit of and priority to U.S. patent application Ser. No. 12/896,364,filed on Oct. 1, 2010, which claims the benefit of and priority to eachof U.S. Provisional Application Ser. No. 61/304,825, filed on Feb. 16,2010, and U.S. Provisional Application Ser. No. 61/249,063, filed onOct. 6, 2009, the entire content of each of which is incorporated hereinby reference.

U.S. patent application Ser. No. 12/896,364 is also aContinuation-in-Part Application claiming the benefit of and priority toU.S. patent application Ser. No. 12/482,049, filed Jun. 10, 2009, nowU.S. Pat. No. 8,628,545, which claims the benefit of and priority toU.S. Provisional Application Ser. No. 61/061,136, filed Jun. 13, 2008,the entire content of each of which is incorporated herein by reference.

BACKGROUND

Technical Field

The present disclosure relates to devices, systems and methods forendoscopic suturing or stitching and, more particularly, to devices,systems and methods for endoscopic suturing and/or stitching through anaccess tube or the like.

Background

As medical and hospital costs continue to increase, surgeons areconstantly striving to develop advanced surgical techniques. Advances inthe surgical field are often related to the development of operativetechniques which involve less invasive surgical procedures and reduceoverall patient trauma. In this manner, the length of hospital stays canbe significantly reduced, and, therefore, the hospital and medical costscan be reduced as well.

One of the truly great advances in recent years to reduce theinvasiveness of surgical procedures is endoscopic surgery. Generally,endoscopic surgery involves incising through body walls for example,viewing and/or operating on the ovaries, uterus, gall bladder, bowels,kidneys, appendix, etc. There are many common endoscopic surgicalprocedures, including arthroscopy, laparoscopy (pelviscopy),gastroentroscopy and laryngobronchoscopy, just to name a few. Typically,trocars are utilized for creating the incisions through which theendoscopic surgery is performed. Trocar tubes or cannula devices areextended into and left in place in the abdominal wall to provide accessfor endoscopic surgical tools. A camera or endoscope is inserted througha relatively large diameter trocar tube which is generally located atthe naval incision, and permits the visual inspection and magnificationof the body cavity. The surgeon can then perform diagnostic andtherapeutic procedures at the surgical site with the aid of specializedinstrumentation, such as, forceps, cutters, applicators, and the likewhich are designed to fit through additional cannulas. Thus, instead ofa large incision (typically 12 inches or larger) that cuts through majormuscles, patients undergoing endoscopic surgery receive morecosmetically appealing incisions, between 5 and I 0 millimeters in size.Recovery is, therefore, much quicker and patients require lessanesthesia than traditional surgery. In addition, because the surgicalfield is greatly magnified, surgeons are better able to dissect bloodvessels and control blood loss. Heat and water loss are greatly reducedas a result of the smaller incisions.

In many surgical procedures, including those involved in endoscopicsurgery, it is often necessary to suture bodily organs or tissue. Thelatter is especially challenging during endoscopic surgery because ofthe small openings through which the suturing of bodily organs ortissues must be accomplished.

In the past, suturing of bodily organs or tissue through endoscopicsurgery was achieved through the use of a sharp metal suture needlewhich had attached at one of its ends a length of suture material. Thesurgeon would cause the suture needle to penetrate and pass throughbodily tissue, pulling the suture material through the bodily tissue.Once the suture material was pulled through the bodily tissue, thesurgeon proceeded to tie a knot in the suture material. The knotting ofthe suture material allowed the surgeon to adjust the tension on thesuture material to accommodate the particular tissue being sutured andcontrol approximation, occlusion, attachment or other conditions of thetissue. The ability to control tension is extremely important to thesurgeon regardless of the type of surgical procedure being performed.

However, during endoscopic surgery, knotting of the suture material istime consuming and burdensome due to the difficult maneuvers andmanipulation which are required through the small endoscopic openings.

Many attempts have been made to provide devices to overcome thedisadvantages of conventional suturing. Such prior art devices haveessentially been staples, clips, clamps or other fasteners. However,none of these above listed devices overcome the disadvantages associatedwith suturing bodily tissue during endoscopic surgery.

Accordingly, there is a need for improvements m suturing devices whichovercome the shortcomings and drawbacks of prior art apparatus.

SUMMARY

An endoscopic stitching device consistent with the present inventioncomprises a handle assembly; an elongate shaft supported by andextending from the handle assembly; and an end effector supported on adistal end of the elongate shaft, the end effector including a neckassembly configured and adapted for articulation in one directionbetween a substantially linear configuration and an off-axisconfiguration, and a pair of juxtaposed jaws pivotally associated withone another, wherein each jaw defines a suture needle receiving recessformed in a tissue contacting surface thereof.

In one embodiment, the jaws that are rotatably supported on the endeffector for selective rotation about a longitudinal axis thereof whenthe end effector is in the substantially linear configuration and in thearticulated configuration. In another embodiment, the handle assemblysupports a rotation assembly configured to transmit an actuation fromthe handle assembly through the elongate shaft to effectuate rotation ofthe jaws. The rotation assembly may include a knob rotatably supportedon a housing of the handle assembly and operatively connected to acenter drive rod assembly, wherein the center drive rod assemblyincludes a distal end extending through the elongate shaft and connectedto the jaws. In some embodiments, at least a portion of the center driverod assembly is flexible. In an embodiment, the endoscopic stitchingdevice includes a center drive rod assembly translatably supportedtherein, the center drive rod assembly including a proximal endoperatively connected to at least one handle of the handle assembly anda distal end extending through the elongate shaft and operativelyconnected to the jaws, wherein axial translation of the center drive rodassembly results in opening and closing of the jaws. In an embodiment,the axial rotation of the center drive rod assembly results in rotationof the jaws about a longitudinal axis thereof. In one embodiment, theendoscopic stitching device includes a rotation assembly supported on ahousing of the handle assembly and operatively connected to the centerdrive rod assembly, wherein actuation of the rotation assembly resultsin concomitant rotation of the center drive rod assembly and the jaws.In an embodiment, at least a portion of a length of the center drive rodassembly is flexible, wherein the flexible portion of the center driverod assembly will flex upon an articulation of the end effector andenable rotation of the jaws when the end effector is in an articulatedcondition.

In an embodiment, the end effector further includes a pair of axiallytranslatable needle engaging blades slidably supported, one each, in arespective jaw, each blade having a first position wherein a portion ofthe blade engages a suture needle when a suture needle is present insuture needle receiving recess formed in the tissue contacting surfaceof the jaw, and a second position wherein the blade does not engage thesuture needle. In accordance with an embodiment, a proximal end of eachblade is rotatably supported on a respective barrel of a concentricbarrel pair, wherein the blades rotate about the barrels upon a rotationof the jaws.

In some embodiments, a suture needle is loadable into the suture needlereceiving recess defined in the jaw when the respective blade is in thesecond position. In one embodiment, the device includes aloading/unloading assembly supported on the handle assembly andconnected to each blade, wherein the loading/unloading assembly ismovable between a first position in which the blades are in the firstposition and a second position in which the blades are in the secondposition. The loading/unloading assembly may be actuatable in a firstdirection to move a first blade to the first position and a second bladeto the second position, and a second direction to move the first bladein the second direction and the second blade in the first direction.

An endoscopic stitching device of the present invention may also includean articulation assembly supported on the handle assembly and actuatableto articulate the end effector, wherein actuation of the articulationassembly results in articulation of the end effector between the linearconfiguration and the off-axis configuration. In one embodiment, thearticulation assembly includes an articulation cam supported on ahousing of the handle assembly and includes first and second cam diskshaving opposing respective first and second camming channels definedtherein, a first pin operably associated with the first camming channeland a first slider configured to longitudinally translate with respectto the housing, and a second pin operably associated with the secondcamming channel and a second slider configured to longitudinallytranslate with respect to the housing, the first and second slidersecured with respective proximal ends of first and second articulationcables, the distal ends being secured at a location distal of the neckassembly, and wherein the articulation cables are disposed on opposedsides of a center drive rod assembly. The first and second cammingchannels may be configured to provide equidistant linear motion directlyproportional to the angular rotation of the first and second cam disks.The first and second camming channels may have a shape substantiallysimilar to a logarithmic spiral. In some embodiments, each articulationcable remains substantially taut upon translation thereof. In anembodiment, the first and second cam disks are monolithically formed. Atorsion spring may operably couple the first and second cam disks. Insome embodiments, the articulation assembly includes an articulationknob supported on a housing of the handle assembly, an articulationsleeve operatively connected to the articulation knob and including apair of oppositely pitched outer helical threads, an articulation collarthreadably connected to each helical thread and configured to permitaxial translation and prevent rotation thereof, and an articulationcable secured to each articulation collar, wherein each articulationcable includes a first end secured to the respective articulation collarand a second end secured at a location distal of the neck assembly, andwherein the articulation cables are disposed on opposed sides of acenter drive rod assembly.

In an embodiment, each articulation cable is operably associated with aseal having first and second lumens extending therethrough, and whereinat least one lumen is configured to receive at least one articulationcable in substantial sealing relationship therewith. At least one of thefirst and second lumens of the seal may have an arched section. In anembodiment, at least one of the first and second lumens of the seal isrepositionable through a plurality of positions including a firstposition and a second position in response to longitudinal translationof at least one articulation cable therethrough. In an embodiment, atleast one lumen of the seal is biased towards at least one of the firstor second positions.

In some embodiments, rotation of the articulation knob results inrotation of the articulation sleeve and concomitant axial translation ofthe articulation collars, wherein axial translation of the articulationcollars results in articulation of the end effector. In an embodiment,rotation of the articulation sleeve in a first direction results inrelative axial separation of the articulation collars to articulate theend effector in a first direction, and rotation of the articulationsleeve in a second direction results in relative axial separation of thearticulation collars to articulate the end effector in a seconddirection.

In one embodiment, the neck assembly includes a plurality of links inpivotable contact with one another, wherein each link includes a knuckleformed on a first side thereof and a clevis formed on a second sidethereof, wherein the knuckle of a first link is operatively connected toa clevis of an adjacent link. In one embodiment, the neck assemblyfurther includes at least one stiffener plate translatably disposed inthe plurality of operatively connected links. In one embodiment, one endof the at least one stiffener plate is securely attached to the neckassembly. The knuckles and devises may be configured to enableuni-directional articulation of the neck assembly. The knuckles anddevises may be configured to at least partially overlap one another whenthe neck assembly is in either the substantially linear configuration orthe off-axis configuration. An endoscopic stitching device according tothe present invention may include a handle assembly that has a pair ofhandles and a center drive rod connected at a first end to the handlesand at a second end to the pair of jaws, wherein actuation of thehandles results in axial translation of the center drive rod andconcomitant opening and closing of the jaws.

An endoscopic stitching device consistent with an embodiment of theinvention includes a handle assembly including a housing; an elongateshaft supported by and extending from the housing; an end effectorsupported on a distal end of the elongate shaft, the end effectorincluding a neck assembly configured and adapted for articulation in onedirection between a substantially linear configuration and an off-axisconfiguration, and a pair of juxtaposed jaws pivotally associated withone another, wherein each jaw defines a suture needle receiving recessformed in a tissue contacting surface thereof, and wherein the jaws arerotatably supported on the end effector for selective rotation about alongitudinal axis thereof when the end effector is in the substantiallylinear configuration and in the articulated configuration; anarticulation assembly supported on the housing and actuatable toarticulate the end effector, wherein actuation of the articulationassembly results in articulation of the end effector between the linearconfiguration and the off-axis configuration; and a rotation assemblysupported on the housing, the rotation assembly being configured totransmit an actuation from the handle assembly through the elongateshaft to effectuate rotation of the jaws.

In an embodiment, the articulation assembly includes an articulation camsupported on a housing of the handle assembly and includes first andsecond cam disks having opposing respective first and second cammingchannels defined therein, a first pin operably associated with the firstcamming channel and a first slider configured to longitudinallytranslate with respect to the housing, and a second pin operablyassociated with the second camming channel and a second sliderconfigured to longitudinally translate with respect to the housing, thefirst and second slider secured with respective proximal ends of firstand second articulation cables, the distal ends being secured at alocation distal of the neck assembly, and wherein the articulationcables are disposed on opposed sides of a center drive rod assembly. Thefirst and second camming channels may be configured to provideequidistant linear motion directly proportional to the angular rotationof the first and second cam disks. The first and second camming channelsmay have a shape substantially similar to a logarithmic spiral. In someembodiments, each articulation cable remains substantially taut upontranslation thereof. In an embodiment, the first and second cam disksarc monolithically formed. A torsion spring may operably couple thefirst and second cam disks.

In an embodiment, the rotation assembly includes a knob rotatablysupported on the housing and operatively connected to a center drive rodassembly, wherein the center drive rod assembly includes a distal endextending through the elongate shaft and connected to the jaws. Therotation assembly may include a beveled gear assembly operativelyassociated with the knob. The beveled gear assembly may be configured totranslate the center drive rod assembly for opening and closing thejaws. The beveled gear assembly may be configured to translaterotational energy to the center drive rod assembly in accordance with atleast one of the following ratios 1:1, more than 1:1, or less than 1:1.In an embodiment, the beveled gear assembly includes a sun gear disposedin mechanical cooperation with the knob and operatively associated withfirst and second beveled gears, the first and second beveled gears beingoperatively associated with each other. The beveled gear assembly mayfurther include a first beveled gear mount disposed in mechanicalcooperation with the first beveled gear and the knob. The second beveledgear may be disposed in mechanical cooperation with the center drive rodassembly. In an embodiment, at least a portion of the center drive rodassembly extending through the neck assembly is flexible.

In one embodiment, the endoscopic stitching device includes a centerdrive rod assembly at least translatably supported in the housing, theelongate shaft and the end effector, and at least rotatably supported inthe elongate shaft and the end effector, the center drive rod assemblyincluding a proximal end operatively connected to at least one handle ofthe handle assembly and a distal end extending through the elongateshaft and operatively connected to the jaws, wherein axial translationof the center drive rod assembly results in opening and closing of thejaws.

In one embodiment, axial rotation of at least a distal portion of thecenter drive rod assembly results in rotation of the jaws about alongitudinal axis thereof. In an embodiment, the end effector furtherincludes a pair of axially translatable needle engaging blades slidablysupported, one each, in a respective jaw, each blade having a firstposition wherein a portion of the blade engages a suture needle when asuture needle is present in suture needle receiving recess fanned in thetissue contacting surface of the jaw, and a second position wherein theblade does not engage the suture needle. A proximal end of each blademay be rotatably supported on a respective barrel of a concentric barrelpair, wherein the blades rotated about the barrels upon a rotation ofthe jaws. A suture needle may be loadable into the suture needlereceiving recess defined in the jaw when the respective blade is in thesecond position.

An endoscopic stitching device consistent with invention may have aloading/unloading assembly supported on the handle assembly andconnected to each blade, wherein the loading/unloading assembly ismovable between a first position in which the blades are in the firstposition and a second position in which the blades are in the secondposition. The loading/unloading assembly may be actuatable in a firstdirection to move a first blade to the first position and a second bladeto the second position, and a second direction to move the first bladein the second direction and the second blade in the first direction.

In an embodiment, the articulation assembly includes an articulationknob supported on the housing of the handle assembly, an articulationsleeve operatively connected to the articulation knob and including apair of oppositely pitched outer helical threads, an articulation collarthreadably connected to each helical thread and configured to permitaxial translation and prevent rotation thereof, and an articulationcable secured to each articulation collar, wherein each articulationcable includes a first end secured to the respective articulation collarand a second end secured at a location distal of the neck assembly, andwherein the articulation cables are disposed on opposed sides of acenter drive rod assembly.

In an embodiment, each articulation cable is operably associated with aseal having first and second lumens extending therethrough, and whereinat least one lumen is configured to receive at least one articulationcable in substantial sealing relationship therewith. At least one of thefirst and second lumens of the seal may have an arched section. At leastone of the first and second lumens of the seal may be repositionablethrough a plurality of positions including a first position and a secondposition in response to longitudinal translation of at least onearticulation cable therethrough. In an embodiment, at least one lumen ofthe seal is biased towards at least one of the first or secondpositions.

In an embodiment, rotation of the articulation knob results in rotationof the articulation sleeve and concomitant axial translation of thearticulation collars, wherein axial translation of the articulationcollars results in articulation of the end effector. In one embodiment,rotation of the articulation sleeve in a first direction results inrelative axial separation of the articulation collars to articulate theend effector in a first direction, and rotation of the articulationsleeve in a second direction results in relative axial separation of thearticulation collars to articulate the end effector in a seconddirection.

An endoscopic stitching device of the invention may have a neck assemblythat includes a plurality of links in pivotable contact with oneanother, wherein each link includes a knuckle formed on a first sidethereof and a clevis formed on a second side thereof, wherein theknuckle of a first link is operatively connected to a clevis of anadjacent link. The neck assembly may further include at least onestiffener plate translatably disposed in the plurality of operativelyconnected links. One end of the at least one stiffener plate may besecurely attached to the neck assembly. The knuckles and devises may beconfigured to enable uni-directional articulation of the neck assembly.The knuckles and devises may be configured to at least partially overlapone another when the neck assembly is in either the substantially linearconfiguration or the off-axis configuration.

In an embodiment, the handle assembly includes a pair of handlessupported on the housing; and a center drive rod connected at a firstend to the handles and at a second end to the pair of jaws, whereinactuation of the handles results in axial translation of the centerdrive rod and concomitant opening and closing of the jaws.

An endoscopic stitching device consistent with an embodiment of theinvention includes a handle assembly; an elongate shaft supported by andextending from the handle assembly; an end effector supported on adistal end of the elongate shaft, the end effector including a neckassembly configured and adapted for articulation in one directionbetween a substantially linear configuration and an off-axisconfiguration, and a pair of juxtaposed jaws pivotally associated withone another; and a stiffener plate disposed in the neck assembly andaxially extending therein, wherein the stiffener plate defines a plane.

In an embodiment, the plane defined by the stiffener plate issubstantially orthogonal to a direction of articulation. The stiffenerplate may be substantially flat, wherein the substantially flatstiffener plate is bendable in one direction. The stiffener plate may betranslatably disposed in the neck assembly. The end effector may bearticulatable in a direction out of the plane defined by the stiffenerplate. In an embodiment, the stiffener plate restricts planararticulation of the end effector with respect to the plane defined bythe stiffener plate. In one embodiment one end of the stiffener plateincludes an anchor portion secured to the neck assembly, wherein theanchor portion may be bifurcated, the bifurcated anchor portionincluding at least a pair of spaced apart tines. In an embodiment, afree end of the stiffener plate is axially tapered with respect to thewidth thereof. In some embodiments, the free end of the stiffener platemay be axially tapered with respect to the thickness thereof. In oneembodiment, the neck assembly includes a plurality of links in pivotablecontact with one another, wherein each link defines a stiffener platereceiving slot for receiving the stiffener plate therethrough. Thestiffener plate may extend through the slot of at least one of thelinks. The stiffener plate, however, may also extend through the slot ofall of the links. The stiffener plate may be made of resilient material.

An endoscopic stitching device consistent with an embodiment of theinvention includes a handle assembly; an elongate shaft supported by andextending from the handle assembly; an end effector supported on adistal end of the elongate shaft, the end effector including a neckassembly configured and adapted for articulation in one directionbetween a substantially linear configuration and an off-axisconfiguration, and a pair of juxtaposed jaws pivotally associated withone another; and a pair of stiffener plates disposed in the neckassembly and axially extending therein, wherein each of the pair ofstiffener plates defines a plane.

In one embodiment, the pair of stiffener plates is substantiallyparallel with one another. The plane defined by each of the pair ofstiffener plates may be substantially orthogonal to a direction ofarticulation. In an embodiment, the pair of stiffener plates issubstantially flat, wherein the pair of substantially flat stiffenerplates is bendable in one direction. In an embodiment, the pair ofstiffener plates is translatably disposed in the neck assembly, whereinthe end effector is articulatable in a direction out of the planedefined by the pair of stiffener plates. In one embodiment, the pair ofstiffener plates restricts planar articulation of the end effector withrespect to the planes defined by the pair of stiffener plates. One endof each of the pair of stiffener plates may include an anchor portionsecured to the neck assembly. The anchor portion may be bifurcated, eachof the bifurcated anchor portion including at least a pair of spacedapart tines. In an embodiment, a free end of the respective stiffenerplate is axially tapered with respect to the width thereof. In anotherembodiment, a free end of the respective stiffener plate is axiallytapered with respect to the thickness thereof. In one embodiment, theneck assembly includes a plurality of links in pivotable contact withone another, wherein each link defines a pair of stiffener platereceiving slots tor receiving the stiffener plates therethrough. Thepair of stiffener plates may extend through the slot of at least one ofthe links. The pair of stiffener plates may also extend through the slotof all of the links. The stiffener plate may be made of resilientmaterial.

DETAILED DESCRIPTION OF THE DRAWINGS

The foregoing objects, features and advantages of the disclosure willbecome more apparent from a reading of the following description inconnection with the accompanying drawings, in which:

FIG. 1 is a perspective view of a flexible stitching device according toan embodiment of the present disclosure;

FIG. 2 is a top, plan view of the flexible stitching device of FIG. 1;

FIG. 3 is a side, elevational view of the flexible stitching device ofFIGS. 1 and 2;

FIG. 4 is a perspective view of an end effector of the flexiblestitching device of FIGS. 1-3;

FIG. 5 is a perspective view of a neck assembly of the flexiblestitching device of FIGS. 1-3;

FIG. 6 is a perspective view of the neck assembly of FIG. 5, as viewedalong line 6-6 of FIG. 5;

FIG. 7 is a top, right-side, perspective view of a handle assembly ofthe flexible stitching device, illustrated with a housing half-sectionremoved therefrom;

FIG. 8 is a top, left-side, perspective view of a handle assembly of theflexible stitching device, illustrated with a housing half-sectionremoved therefrom;

FIG. 9 is a perspective view, with parts separated, of the flexiblestitching device;

FIG. 10 is a perspective view, with parts separated, of a needle loadassembly and an end effector articulation assembly of the flexiblestitching device;

FIG. 11 is a perspective view of a suture needle assembly of the presentdisclosure;

FIG. 12 is a perspective view, with parts separated, of a needleretention assembly of the flexible stitching device;

FIG. 13 is a perspective view, with parts assembled, of the needleretention assembly of FIG. 12;

FIG. 14 is a longitudinal, cross-sectional view of the needle retentionassembly of FIGS. 12 and 13, as taken through 14-14 of FIG. 13;

FIG. 15 is a longitudinal, cross-sectional view of the flexiblestitching device of the present disclosure, as taken through 15-15 ofFIG. 3;

FIG. 16 is a longitudinal, cross-sectional view of the flexiblestitching device of the present disclosure, as taken through 16-16 ofFIG. 15;

FIG. 17 is an enlarged view of the indicated area of detail of FIG. 15;

FIG. 18 is an enlarged view of the indicated area of detail of FIG. 16;

FIG. 19 is an enlarged view of the indicated area of detail of FIG. 15;

FIG. 20 is an enlarged view of the indicated area of detail of FIG. 16;

FIG. 21 is a cross-sectional view of the handle assembly, as takenthrough 21-21 of FIG. 20;

FIG. 22 is a cross-sectional view of a jaw of the end effector assembly,as taken through 22-22 of FIG. 17;

FIG. 23 is a cross-sectional view of the handle assembly, of theflexible stitching device, illustrating an initial actuation of thehandles thereof;

FIG. 24 is a cross-sectional view of the end effector assembly, of theflexible stitching device, during the initial actuation of the handleassembly;

FIG. 25 is an enlarged view of the indicated area of detail of FIG. 24:

FIG. 26 is a cross-sectional view of the jaw of the end effectorillustrating the needle of the suture needle assembly disposed therein;

FIG. 27 is a cross-sectional view illustrating the movement of theneedle load assembly during the initial actuation of the handleassembly;

FIG. 28 is a cross-sectional view of the needle load assembly of FIG. 27as taken through 28-28 of FIG. 27;

FIG. 29 is a perspective view of a housing half-section of the flexiblestitching device;

FIG. 30 is an enlarged view of the indicated area of detail of FIG. 29;

FIG. 31 is a cross-sectional view of the handle assembly, of theflexible stitching device, illustrating a release of handles thereof andan actuation of a needle retention assembly;

FIG. 32 is a plan view further illustrating the actuation of the needleretention assembly;

FIG. 33 is a longitudinal, cross-sectional view of the end effectorassembly, illustrating the loading of a suture needle assembly therein;

FIG. 34 is a cross-sectional view of the end effector assembly as takenthrough 34-34 of FIG. 33;

FIG. 35 is a cross-sectional view of the end effector assembly as takenthrough 35-35 of FIG. 33;

FIG. 36 is a cross-sectional view of the handle assembly, of theflexible stitching device, illustrating a further actuation of theneedle retention assembly;

FIG. 37 is a longitudinal, cross-sectional view of the end effectorassembly, illustrating the positioning of the needle of the sutureneedle assembly in an opposite jaw thereof;

FIG. 38 is a cross-sectional view of the handle assembly as takenthrough 38-38 of FIG. 8;

FIG. 39 is a cross-sectional view of the handle assembly as takenthrough 39-39 of FIG. 8;

FIG. 40 is a longitudinal cross-sectional view of the handle assembly,illustrating an actuation of the articulation assembly;

FIG. 41 is a perspective view, with parts separated, of the neckassembly of the flexible stitching device;

FIG. 42 is a perspective view of a link of the neck assembly of FIG. 41;

FIG. 43 is a cross-sectional view of the end effector, illustrating anarticulation thereof;

FIG. 44 is a perspective view of the end effector of FIG. 43;

FIG. 45 is a cross-sectional view of the handle assembly as takenthrough 45-45 of FIG. 7, illustrating an operation of a rotationassembly of the flexible stitching device;

FIG. 46 is a cross-sectional view of the handle assembly as takenthrough 46-46 of FIG. 7, illustrating a further operation of a rotationassembly of the flexible stitching device;

FIG. 47 is a perspective view illustrating the connection of a distalcenter rod and a proximal center rod, including a coupling sleeve;

FIG. 48 is a perspective view illustrating the connection of the distalcenter rod and the proximal center rod, with the coupling sleeve removedtherefrom;

FIG. 49 is a perspective view, with parts separated, of the connectionof a distal link of the neck portion of the end effector assembly to adistal support member of the end effector assembly;

FIG. 50 is an enlarged view of the indicated area of detail of FIG. 49;

FIG. 51 is a longitudinal cross-sectional view illustrating theconnection of the distal link of the neck assembly the distal supportmember;

FIG. 52 is an enlarged view of the indicated area of detail of FIG. 51;

FIG. 53 is a perspective view of the end effector assembly, illustratinga rotation thereof;

FIG. 54 is a front, perspective view of an end effector rotationassembly according to another embodiment of the present disclosure;

FIG. 55 is a rear, perspective view of the end effector rotationassembly of FIG. 54;

FIG. 56 is a perspective view, with parts separated, of the end effectorrotation assembly of FIGS. 54 and 55;

FIG. 57 is a rear, perspective view of the end effector rotationassembly of FIGS. 54-56, illustrating an operation thereof;

FIG. 58 is a front, perspective view of an end effector rotationassembly according to still another embodiment of the presentdisclosure;

FIG. 59 is a cross-sectional view of the end effector rotation assemblyof FIG. 58, as taken through 59-59 of FIG. 58;

FIG. 60 is a perspective view, with parts separated, of the end effectorrotation assembly of FIGS. 58 and 59;

FIG. 61 is a cross-sectional view of the end effector rotation assemblyof FIGS. 58-60, as taken through 61-61 of FIG. 58;

FIG. 62 is the cross-sectional view of FIG. 59, illustrating anoperation of the end effector rotation assembly of FIGS. 58-61;

FIG. 63 is a longitudinal, cross-sectional view of another embodiment ofthe distal end of a flexible stitching device of the present disclosure,including an arched seal therein;

FIG. 64 is an enlarged view of the indicated area of detail of FIG. 63,with the arched seal being illustrated in a first position;

FIG. 65 is a perspective view of the arched seal of FIG. 63;

FIG. 66 is a perspective, longitudinal, cross-sectional view of thearched seal of FIGS. 63-65, as taken through 66-66 of FIG. 65;

FIG. 67 is a transverse, cross-sectional view of the arched seal ofFIGS. 63-66, as taken through 67-67 of FIG. 64;

FIG. 68 is a longitudinal, cross-sectional view of the arched seal ofFIGS. 63-67, with the arched seal being illustrated in a secondposition;

FIG. 69 is a transverse, cross-sectional view of the arched seal ofFIGS. 63-68, as taken through 69-69 of FIG. 68;

FIG. 70 is a longitudinal, cross-sectional view of an end effectorrotation assembly according to another embodiment of the presentdisclosure;

FIG. 71 is a perspective view of a gear assembly of the end effectorrotation assembly of FIG. 70;

FIG. 72 is a cross-sectional view of the end effector rotation assemblyof FIGS. 70 and 71, as taken through 72-72 of FIG. 70;

FIG. 73 is a perspective view of another embodiment of a handle assemblyof the flexible stitching device, including another embodiment of anarticulation assembly therein;

FIG. 74 is an enlarged perspective view of the handle assembly of FIG.73 with the housing removed to illustrate the articulation assembly;

FIG. 75 is a perspective view, with parts separated, of the articulationassembly of FIGS. 73-74;

FIG. 76 is a side elevational view of an articulation cam of thearticulation assembly of FIGS. 73-75, with the articulation cam beingillustrated in a first position;

FIG. 77 is a side elevational view of the articulation cam of FIG. 76with the articulation cam being illustrated in a second position;

FIG. 78 is a side elevational view of the articulation cam of FIGS.76-77 with the articulation cam being illustrated in a third position;

FIG. 79 is a perspective view of another embodiment of an articulationcam in accordance with the present disclosure;

FIG. 80 is a top plan schematic view of another embodiment of anarticulation assembly in accordance with the present disclosure;

FIG. 81 is a top plan schematic view of another embodiment of anarticulation assembly in accordance with the present disclosure;

FIG. 82 is a side elevational schematic view of another embodiment of anarticulation assembly in accordance with the present disclosure;

FIG. 83 is a perspective, longitudinal, cross-sectional view of anotherembodiment of the neck assembly in accordance with the presentdisclosure, incorporating therein two stiffener plates;

FIG. 84A is a distal end view of a stem of the neck assembly of FIG. 83,configured to receive the two stiffener plates;

FIG. 84B is a perspective view of the stem of FIG. 84A, illustrated witha portion cut away therefrom;

FIG. 85A is a proximal end view of a link of the neck assembly of FIG.83, configured to receive the two stiffener plates;

FIG. 85B is a perspective view of the link of FIG. 85A, illustrated witha portion cut away therefrom;

FIG. 86 is a cross-sectional view of another embodiment of a link of aneck assembly in accordance with the present disclosure, incorporatingtherein two stiffener plates;

FIG. 87 is a longitudinal. cross-sectional view of the neck assembly ofFIG. 83 as taken through 87-87 of FIG. 83;

FIG. 88 is another longitudinal, cross-sectional view of the neckassembly of FIG. 83; and

FIG. 89 is a perspective view of a drive assembly according to anotherembodiment of the present disclosure.

DETAILED DESCRIPTION OF EMBODIMENTS

The present disclosure relates to devices, systems and methods forendoscopic, laparoscopic, endoluminal, and/or transluminal suturing. Inone embodiment, for example, such a device comprises a handle. handleassembly or other suitable actuating mechanism (e.g., robot, etc.)connected to a proximal end of a flexible, elongated body portion. Aneck assembly operatively supported on a distal end of the flexible,elongated body portion allows an end effector, operatively supported ata distal end of the neck assembly, to articulate in response toactuation of articulation cables. The end effector includes a sutureneedle and a pair of jaws. In operation, the suture needle is passedback and forth through tissue from one jaw to the other. The device isadapted to be placed in a lumen of a flexible endoscope and theninserted into a natural orifice of a patient and transited endoluminallythrough the anatomy of the natural lumen to a treatment site within oroutside the natural lumen.

In the drawings and in the description which follow, the term“proximal”, as is traditional, will refer to the end of the device whichis closest to the operator, while the term “distal” will refer to theend of the device which is furthest from the operator.

Referring now in specific detail to the drawings, in which likereference numbers identify similar or identical elements, FIGS. 1-3illustrate a flexible stitching device, shown generally at 100.Stitching device 100 is adapted to be particularly useful in endoscopicor laparoscopic procedures wherein an endoscopic portion of thestitching device, i.e., end effector, is insertable into an operativesite, via a cannula assembly or the like (not shown).

As seen in FIGS. 1-3, stitching device I 00 includes an end effector 200of supportable on or extends from a handle assembly 300 and/or a distalend of an elongate tubular body portion 308 extending distally fromhandle assembly 300.

As seen in FIGS. 1-6, 9, 41 and 42, end effector 200 includes a neckassembly 210 supported on a distal end of shaft 308 extending fromhandle assembly 300, and a tool or jaw assembly 220 supported on adistal end of neck assembly 210. Neck assembly 210 includes a pluralityof links 212 each including a proximal knuckle 212 a and a distal clevis212 b formed therewith. As seen in FIGS. 41 and 42, each knuckle 212 aoperatively engages a clevis 212 b of an adjacent link 212. Each link212 defines a central lumen 212 c (sec FIG. 42) formed therein and twopair of opposed lumen 212 d 1, 212 d 2 and 212 e 1, 212 e 2,respectively, formed on either side of central lumen 212 c. A pair ofarticulation cables 340, 342, slidably extend through respective lumens212 e 1, 212 e 2, of links 212.

Links 212 are configured to enable end effector 200 to move between asubstantially linear configuration and a substantially angled, off-axisor articulated configuration. Links 212 are also configured so as topermit end effector 200 to be articulated in solely a single direction.For example, as seen in FIGS. 5 and 6, when end effector 200 is in alinear condition, the knuckles and devises on a first side of centrallumen 212 c are fully seated within one another, and the knuckles andclevises on a second side of central lumen 212 c arc not fully seatedwithin one another, thereby permitting end effector 200 to bearticulated in the direction of the not fully seated side of centrallumen 212 c. Moreover, the knuckles and corresponding devises aredimensioned such that when end effector 200 is in the substantiallylinear configuration, the knuckles and the corresponding devises on thenot fully seated side of central lumen 212 c are at least aligned withone another or at least partially overlap one another. In this manner,the possibility of tissue, vessels or other body structures gettingcaught or pinched therebetween is reduced.

Operation of neck assembly 210 to articulate end effector 200thereabout, will be discussed in greater detail below.

As seen in FIGS. 1-4, 9, 49 and 50, jaw assembly 220 of end effector 200includes a jaw support member 222, and a pair of jaws 230, 232 mountedfor pivotable movement on jaw support member 222. Jaw support member 222defines a lumen 224 in a proximal end thereof and a pair of spaced apartarms 226 in a distal end thereof. As seen in FIG. 49, lumen 224 isconfigured and dimensioned to receive a stem 212 f extending from adistal-most link 212 of neck assembly 210.

As seen in FIGS. 49-52, jaw support member 222 defines an annular groove224 a formed in a surface of lumen 224 thereof and stem 212 f defines anannular race 212 f 1 formed in an outer surface thereof. An annulargroove 224 a formed in a surface of lumen 224 of jaw support member 222and annular race 212 f 1 formed in the outer surface of stem 212 f arein registration with one another when stem 212 f is connected to jawsupport member 222. A ring 213 is disposed within annular groove 224 aformed in a surface of lumen 224 of jaw support member 222 and annularrace 212 f, formed in the outer surface of stem 212 f to therebymaintain stem 212 f connected to jaw support member 222 and permitrotation of jaw support member 222 relative to stem 212 f.

As seen in FIGS. 4, 17 and 18, each jaw 230, 232 includes a needlereceiving recess 230 a, 232 a, respectively, configured to surround andhold at least a portion of a needle 104 of a suture needle assembly 102disposed therein substantially perpendicular to tissue engaging surfacesthereof. As seen in FIG. 11, needle 104 includes a groove 104 a formednear each end thereof. A suture 106 may be secured to surgical needle104 at a location between grooves 104 a.

Suture 106 of suture needle assembly 104 may comprise a one-way orbarbed suture, wherein the suture includes an elongated body having aplurality of barbs extending therefrom. The barbs arc oriented in such away that the barbs cause the suture to resist movement in an oppositedirection relative to the direction in which the barb faces.

Suitable sutures for use with suture needle assembly 104 include, andare not limited to, those sutures described and disclosed in U.S. Pat.NoS. 3,123,077; 5,931,855; and U.S. Patent Publication No. 2004/0060409,filed on Sep. 30, 2002, the entire content of each of which beingincorporated herein by reference.

Jaws 230, 232 are pivotably mounted on support member 222 by means of ajaw pivot pin 234 which extends through holes 226 a formed in arms 226of support member 222 and respective pivot holes 230 b, 232 b formed injaws 230, 232. To move jaws 230, 232 between an open position and aclosed position there is provided an axially or longitudinally movablecenter drive rod assembly 236 having a camming pin 238 mounted at adistal end of a center drive rod distal portion 236 a. Camming pin 238rides in and engages angled camming slots 230 c, 232 c formed inrespective jaws 230, 232 such that axial or longitudinal movement ofcenter rod assembly 236 causes jaws 230, 232 to be cammed between openand closed positions.

Jaw assembly 220 includes a drive assembly 240 slidably and rotatablydisposed within lumen 224 of support member 222. As seen in FIGS. 9 and12-14, drive assembly 240 includes an inner drive assembly 242 and anouter drive assembly 244. Inner drive assembly 242 includes an innerbarrel or collar 242 a defining a lumen 242 b therethrough. Lumen 242 bis configured to slidably and rotatably receive center drive rod distalportion 236 a of center drive rod assembly 236 therein. Inner driveassembly 242 further includes a cuff 250 a slidably and/or rotatablysupported on inner barrel 242 a, and a first blade 250 b extending fromcuff 250 a. Blade 250 b extends from cuff 250 a in a directionsubstantially parallel to a central longitudinal axis of lumen 242 b ofinner barrel 242 a.

As seen in FIGS. 9 and 12-14, outer drive assembly 244 includes an outerbarrel or collar 244 a defining a lumen 244 b therethrough and anannular recess 244 c formed in a surface of lumen 244 b. Lumen 244 b isconfigured to slidably and rotatably receive inner barrel 242 a therein,such that inner barrel 242 a is nested within lumen 244 b of outerbarrel 244 a. Outer drive assembly 244 further includes a cuff 252 aslidably and/or rotatably supported in annular recess 244 c, and asecond blade 252 b extending from ring 244 d. Blade 252 b extends fromcuff 252 a in a direction substantially parallel to a centrallongitudinal axis of lumen 244 b of outer barrel 244 a.

Jaw assembly 220 further includes a clevis 246 disposed between arms 226of support member 222. Clevis 246 includes a pair of spaced apart arms246 b extending from a base 246 a. Each arm 246 b defines a lumen 246 ctherethrough. Clevis 246 defines a central aperture 246 d formed in base246 a. Arms 246 b arc spaced apart an amount sufficient and centralaperture 246 d of base 246 b is dimensioned so as to slidably androtatably receive distal portion 236 a of center rod assembly 236therethrough.

Jaw assembly 220, as discussed above, further includes a pair of needleengaging members or blades 250 b, 252 b which are slidably supportedwithin a respective lumen 246 c of arms 246 b of clevis 246. Each blade250 b, 252 b includes a distal end slidably extending into bladereceiving channels 230 d, 232 d (see FIG. 17) of respective jaws 230,232. Each blade 250 b, 252 b is resilient so as to flex or bend as jaws230, 232 are opened and closed and still translate relative thereto whenjaws 230, 232 are in either the open or closed condition.

In operation, as inner drive assembly 242 and outer drive assembly 244are translated, in an axial direction, relative to one another. blades250 b, 252 b are also translated with respect to one another.

Turning now to FIGS. 1-3 and 7-10, a detailed discussion of handleassembly 300 is provided. Handle assembly 300 includes a housing 302having an upper housing half 304 and a lower housing half 306. Handleassembly 300 further includes a pair of handles 310 pivotably secured tohousing 302 and extending outwardly therefrom.

Housing halves 304, 306 of flexible stitching device may be joinedtogether by snap-fit engagement or by suitable fasteners (e.g., screws)or the like. Housing 302 defines a window 304 a, 306 a respectivelyformed in housing halves 304, 306. Windows 304 a, 306 a of housinghalves 304, 306 are dimensioned to receive and provide access to anarticulation assembly 330.

As seen in FIG. 9, handles 310 are secured to housing 302 at handlepivot posts. Handle assembly 300 includes a link member 312 having afirst end pivotably connected to each handle 310 at a pivot point 310 aformed in a respective handle 310 and a second end pivotally connectedto one another and pivotally connected to a proximal portion 236 b ofcenter drive rod assembly 236 via a drive pin 316. Each end of drive pin316 is slidably received in a respective elongate channel 304 b, 306 bof housing halves 304, 306. In use, as will be described in greaterdetail below, as handles 310 are squeezed, link members 312 push centerdrive rod assembly 236 proximally via drive pin 316.

As mentioned above, handle assembly 300 includes a center drive rodassembly 236 translatably supported in housing 302. Handle assembly 300includes a biasing member 318, in the form of a return spring, supportedon proximal portion 236 b of center drive rod assembly 236 and held inplace between a surface 306 c formed in lower housing half 306 and aretaining clip 318 a connected to proximal portion 236 b of center driverod assembly 236.

As seen in FIGS. 9, 47 and 48, a distal end proximal portion 236 b ofcenter drive rod assembly 236 is rotatably connected to a proximal endof an intermediate portion 236 c of center drive rod assembly 236. Inthis manner, intermediate portion 236 c of center drive rod assembly 236is free to rotate relative to proximal portion 236 b of center drive rodassembly 236. A sleeve 237 may be provided to maintain intermediateportion 236 c of center drive rod assembly 236 and proximal portion 236b of center drive rod assembly 236 connected to one another.Intermediate portion 236 c of center drive rod assembly 236 is connectedto distal portion 236 a of center drive rod assembly 236. In operation,as proximal portion 236 b of center drive rod assembly 236 is translatedupon the actuation of handles 310, said translation is transmitted tointermediate portion 236 c and distal portion 236 a of center drive rodassembly 236. As described above, as distal portion 236 a of centerdrive rod assembly 236 is translated camming pin 238, mounted to distalportion 236 a of center drive rod assembly 236, rides in and engagesangled camming slots 230 c, 232 c formed in respective jaws 230, 232 tocause jaws 230, 232 to be cammed between open and closed positions.

Handle assembly 300 further includes an articulation assembly 330rotatably supported in housing 302. Articulation assembly 330 includes athreaded articulation sleeve 332 rotatably supported and axially fixedon center drive rod 314, at a location distal of biasing member 318.Threaded articulation sleeve 332 defines a distal thread and a proximalthread 332 a, 332 b, respectively.

As seen in FIGS. 9, 10, 19 and 20, articulation assembly 330 furtherincludes a distal articulation collar 334 a and a proximal articulationcollar 334 b operatively connected to a respective thread 332 a, 332 bof articulation sleeve 332. Each collar 334 a, 334 b defines a pair ofradially extending tabs 334 a 1, 334 b 1, respectively, that are inslidably engagement in elongate slots 304 d, 306 d (see FIG. 20) ofupper and lower housing halves 304, 306, respectively. Threads 332 a,332 b of articulation sleeve 332 and respective threads of distal andproximal articulation collars 334 a, 334 b are configured such thatrotation of articulation sleeve 332 results in either approximation ofdistal and proximal articulation collars 334 a, 334 b relative to oneanother when articulation sleeve 332 is rotated in a first direction orseparation of distal and proximal articulation collars 334 a, 334 brelative to one another when articulation sleeve 332 is rotated in asecond direction. It is contemplated that the pitch of the threadsbetween articulation sleeve 332 and articulation collars 334 a, 334 bmay be selected as necessary to achieve the intended purpose ofapproximating or separating the collars 334 a, 334 b relative to oneanother.

Articulation assembly 330 further includes an articulation disk 336rotatably disposed in housing 302 and keyed or otherwise secured toarticulation sleeve 332. In this manner, as articulation disk 336 isrotated, concomitant rotation is transmitted to articulation sleeve 332and to distal and proximal articulation collars 334 a, 334 b.Articulation disk 336 is keyed or otherwise connected to an articulationknob 338 rotatably supported in housing 302 and accessible throughwindows 304 a, 306 a of upper and lower housing halves 304, 306. Inoperation, as articulation knob 338 is rotated, said rotation istransmitted to articulation disk 336.

Articulation assembly 330 further includes a pair of articulation cables340, 342 extending through and secured to end effector 200 and handleassembly 300. A first articulation cable 340 includes a first endsecured to proximal articulation collar 334 b and a second end extendingthrough distal articulation collar 334 a, through a respective slot inarticulation disk 336, through respective lumen 212 e 1 of links 212,and secured to distal-most link 212 or stem 212 f of neck portion 210(see FIG. 18). A second articulation cable 342 includes a first endsecured to distal articulation collar 334 a and a second end extendingthrough a respective slot in articulation disk 336, through respectivelumen 212 e 2 of links 212, and secured to distal-most link 212 or stem212 f of neck portion 210 (see FIG. 18).

In operation, as will be described in greater detail below, asarticulation knob 338 is rotated, rotation is transmitted toarticulation disk 336 and on to articulation sleeve 332. As articulationsleeve 332 is rotated, distal and proximal articulation collars 334 a,334 b are approximated and/or separated relative to one another, andthus cause retraction of either first or second articulation cable 340,342, depending on the direction of rotation of articulation knob 338.

Articulation assembly 330 further includes a biasing member 346supported on intermediate portion 236 c of center drive rod assembly236.

As seen in FIGS. 1-3 and 7-14, handle assembly 300 further includes aneedle loading/retaining assembly 350 supported thereon. Needleloading/retaining assembly 350 includes a lever 352 pivotably supportedin housing 302 and having a pair of arms 354 a, 354 b extendingtherefrom. Needle loading/retaining assembly 350 further includes afirst blade control rod 356 a and a second blade control rod 356 b. Eachblade control rod 356 a, 356 b includes a proximal end connected tolever 352 at opposed sides of a pivot axis. In this manner, as lever 352is actuated or pivoted in a first direction, first blade control rod 356a is moved in a first direction and second blade control rod 356 b ismoved in a second direction, opposite to the first direction, andvice-versa. A distal end of each blade control rod 356 a, 356 b isconnected to a respective inner drive assembly 242 and outer driveassembly 244, in particular, to respective inner barrel 242 a and outerbarrel 244 a of drive assembly 240.

As seen in FIGS. 12-14, needle loading/retaining assembly 350 furtherincludes resilient bendable rods 358 a, 358 b interconnecting the distalend of each blade control rod 356 a, 356 b to respective inner barrel242 a and outer barrel 244 a of drive assembly 240. As seen in FIGS. 13and 14, a rod 359 a, 359 b may interconnect respective distal ends ofblade control rods 356 a, 356 b and inner and outer barrels 242 a, 244a.

As seen in FIGS. 9, 10, 20-22 and 26-30, needle loading/retainingassembly 350 further includes a pair of needle loading/unloading buttons360, 362 supported on housing 302. Needle loading/unloading buttons 360,362 are slidable between a distal-most position and a proximal-mostposition. When needle loading/unloading buttons 360, 362 are in thedistal-most position, blades 250 b, 252 b are in a distal-most positionsuch that a respective notch 250 c, 252 c formed therein, as seen inFIG. 22, is aligned with or in registration with respective needlereceiving openings 230 a, 232 a of respective jaws 230, 232. With blades250 b, 252 b in a distalmost position, needle 104 of suture needleassembly I 02 may be placed into a selected needle receiving opening 230a, 232 a of a selected jaw 230, 232. When needle loading/unloadingbuttons 360, 362 are in the proximal-most position blades 250 b, 252 bare in a proximal-most position such that the respective notch 250 c,252 c formed therein is out of aligned with or registration withrespective needle receiving openings 230 a, 232 a of respective jaws230, 232. With blades 250 b, 252 b in the proximal-most position, needle104 of suture needle assembly I 02, placed into the selected needlereceiving opening 230 a, 232 a of a selected jaw 230, 232, is held inplace due to the blade 250 b, 252 b engaging a groove 1 04 a of needle104.

As seen in FIGS. 9, 20 and 21, each button 360, 362 is supported on arespective biased stem 360 a, 362 a by a respective biasing member 360b, 362 b. As seen in FIGS. 21 and 27-30, stems 360 a, 360 b arc slidablydisposed within respective slots 304 e, 306 e of upper and lower housinghalves 304, 306. Each slot 304 e, 306 e includes an enlarged proximalend 304 f, 306 f configured to receive a portion of a respective stem360 a, 362 a therein as buttons 360, 362 are moved to a proximalposition. In order to move buttons 360, 362 in a distal direction, oncestems 360 a, 362 a have seated in enlarged proximal ends 304 f, 306 f ofslots 304 e, 306 e of upper and lower housing halves 304, 306, the usermust depress buttons 360, 362 to move stems 360 a, 362 a out of enlargedproximal ends 304 f, 306 f of slots 304 e, 306 e and thus allow forbuttons 360, 362 to move distally.

As seen in FIGS. 9, 10, 20 and 27, needle loading/retaining assembly 350is supported on a frame or bracket 368. Bracket 368 is movable distallyand proximally with lever 352 and is configured to permit passage ofcenter drive rod assembly 236 therethrough. As seen in FIG. 27, biasingmember 346 is interposed between bracket 368 and articulation sleeve332. In use, as buttons 360, 362 are moved in a proximal direction,bracket 368 is moved in a proximal direction to compress biasing member346. In this manner, when buttons 360, 362 are depressed to disengagestems 360 a, 362 a from enlarged proximal ends 304 f, 306 f of slots 304e, 306 e, biasing member 346 is permitted to expand the thus returnbuttons 360, 362 to a distal position.

As seen in FIGS. 1-3, 7-10, 45 and 46, handle assembly 300 furtherincludes a tip rotation assembly 370 supported on housing 302 forrotating end effector 200 about the longitudinal axis thereof. Tiprotation assembly 370 includes a rotation knob 372 supported on housing302. Rotation knob 372 defines an annular array of internal gear teeth372 a. Tip rotation assembly 370 includes a gear system 374 supported ona frame 376 in housing 302. Gear system 374 includes at least a firstgear 374 a operatively engaged with gear teeth 372 a of rotation knob372, at least a second gear 374 b keyed to or otherwise connected tointermediate portion 236 c of center drive rod assembly 236, and atleast a third gear 374 c interconnecting the first gear 374 a and thesecond gear 374 b such that the direction of rotation of rotation knob372 results in concomitant rotation of the intermediate portion 236 cand the distal portion 236 a of center drive rod assembly 236 and, intum, end effector 200. As intermediate portion 236 c and distal portion236 a of center drive rod assembly 236 is rotated, said rotation istransmitted to caroming pin 238 of jaws 230, 232 and thus rotation istransmitted to end effector 200. Since blades 250 b, 252 b are rotatablysupported on respective barrels 242 a, 244 a, blades 250 b, 252 b alsorotate with end effector 200.

Turning now to FIGS. 15-53, a detailed discussion of the operation offlexible endoscopic stitching device 100 is provided. As seen in FIGS.15-22, stitching device 100 is shown in a needle load/unloadconfiguration. When stitching device 100 is in the needle load/unloadconfiguration, as seen in FIGS. 16 and 20, needle loading/retainingassembly 350 is in a distal position such that blades 250 b, 252 b arein a distal-most position and, as seen in FIG. 22, respective notches250 c, 252 c formed therein, are aligned with or in registration withrespective needle receiving openings 230 a, 232 a of respective jaws230, 232. With notches 250 c, 252 c of blades 250 b, 252 b aligned withor in registration with respective needle receiving openings 230 a, 232a of respective jaws 230, 232, as seen in FIGS. 24-26, needle 104 ofsuture needle assembly 102 may be positioned or loaded into a selectedone needle receiving opening 230 a, 232 a of respective jaws 230, 232.

As seen in FIGS. 23-26, once needle 104 is loaded into either needlereceiving opening 230 a, 232 a of respective. jaws 230, 232, handles 310are actuated (e.g., squeezed) to move link members 312 and, in tum,axially displace center drive rod assembly 236 in a proximal direction(as indicated by arrow “A” of FIGS. 23 and 24). As seen in FIGS. 24 and25, as center drive rod assembly 236 is moved in a proximal direction,camming pin 238 is moved in a proximal direction to approximate jaws230, 232.

As seen in FIG. 27, once needle 104 is loaded into either needlereceiving opening 230 a, 232 a of respective jaws 230, 232, needleloading/retaining assembly 350 is moved in a proximal direction tothereby retract blades 250 b, 252 b and cause each blade 250 b, 252 b toengage a respective groove 104 a of needle 104.

As seen in FIGS. 31-35, with needle 104 engaged by both blades 250 b,252 b, as seen in FIGS. 31 and 32, lever 352 is actuated or rotated sothat only one blade 250 b, 252 b, e.g., blade 252 b, is maintained inengagement with needle 104, as seen in FIG. 35, and the other blade 250b is disengaged from needle 104, as seen in FIG. 34. With only oneblade, e.g., blade 252 b, engaged with needle 104, as seen in FIGS.33-35, handles 310 may be released, as seen in FIG. 31, thereby movingcenter drive rod assembly 236 and camming pin 238 in a distal directionto open jaws 230, 232.

With jaws 230, 232 open, end effector 200 may be positioned at thesurgical site as needed, and handles 310 reactuated to approximate jaws230, 232. For example, with jaws 230, 232 in an open position and needle104 loaded therein, jaws 230, 232 may be positioned about or over atarget tissue and handles 310 actuated to approximate jaws 230, 232. Asjaws 230, 232 are approximated, the exposed end of needle 104 ispenetrated through the target tissue and enters into the opposed jaw230, 232. With needle 104 in the opposed jaw 230, 232, as seen in FIG.36, lever 352 is once again actuated or rotated so that blades 250 b,252 b are reversed. In so doing, blade 252 b is disengaged from needle104 and blade 250 b is engaged with needle 104.

As seen in FIG. 37, with needle 104 engaged by blade 250 b, handles 310may be released to thereby open jaws 230, 232 and draw needle 104through the target tissue. In so doing, suture 106 is also drawn throughthe tissue. The process is repeated numerous times passing the needle104 between jaws 230, 232 and drawing suture through the target tissuethereby suturing the target tissue as needed and or desired.

During a surgical procedure, if desired or necessary, as seen in FIGS.38-44, a user may actuate articulation knob 338 of articulation assembly330 to effectuate articulation or off-axis movement of end effector 200.In particular, as articulation knob 338 is rotated, rotation istransmitted to articulation disk 336 and on to articulation sleeve 332.As articulation sleeve 332 is rotated, distal and proximal articulationcollars 334 a, 334 b are moved from an approximated condition to a moreseparated condition relative to one another, thus causing retraction offirst articulation cable 340 and extension of second articulation cable342.

As seen in FIGS. 43 and 44, as first articulation cable 340 is retractedand second articulation cable 342 is extended, end effector 200 isarticulated at neck portion 210. As end effector 200 is articulated,intermediate portion 236 c of center drive rod assembly 236 is flexed.In this manner, end effector 200 is still capable of rotation about itsaxis and jaws 230, 232 are still capable of opening and closing.

As seen in FIG. 44, while in an articulated condition, links 212 remainat least partially over-lapped in order to inhibit entry of tissue ofthe like therebetween. In this manner, when end effector 200 is returnedto un-articulated or linear condition, tissue will not be caught orpinched between links 212 of neck portion 210.

During a surgical procedure, if desired or necessary, as seen in FIGS.45-53, a user may actuate rotation knob 372 of tip rotation assembly 370to effectuate rotation of end effector 200 along a longitudinal axisthereof. In particular, as rotation knob 372 is rotated intermediateportion 236 c and distal portion 236 a of center drive rod assembly 236is rotated. As intermediate portion 236 c and distal portion 236 a ofcenter drive rod assembly 236 is rotated, said rotation is transmittedto camming pin 238 of jaws 230, 232 and thus rotation is transmitted toend effector 200.

Turning now to FIGS. 54-57, a tip rotation assembly according to anotherembodiment of the present disclosure, for use with stitching device 100,is generally designated as 470. Tip rotation assembly 470 includes arotation knob 472 supported on housing 302. Knob 472 defines an arcuateslot 472 a formed in a rear surface thereof and which arcuate slot 472 aextends radially outward from a central rotational axis of knob 472 andextends approximately 180° about the central rotational axis. Tiprotation assembly 470 includes a collar 474 keyed to or otherwisesecured to center drive rod assembly 236. Tip rotation assembly 470further includes a wishbone link 476 having a first end 476 a pivotallyconnected to collar 474 and a second end 476 b pivotally supporting apiston 478. First end 476 a of link 476 is curved about an axistransverse to a pivot axis thereof, so as to define a pocket 476 cconfigured to selectively receive center drive rod assembly 236 therein.A pin 479 extends though piston 478 and connects piston 478 to arcuateslot 472 a.

Rotation assembly 470 includes a home position in which pin 479 islocated at a first end of arcuate slot 472 a, where the arcuate slot 472a is furthest from the center drive rod assembly 236.

In operation, in order to rotate end effector 200 about the longitudinalaxis thereof, rotation knob 472 is rotated from the home position. Asrotation knob 472 is rotated, pin 479 slidably translates througharcuate slot 472 a, approximating pin 479 toward center drive rodassembly 236. As pin 479 is approximated toward center drive rodassembly 236, wishbone link 476 is provided with sufficient clearance inorder for wishbone link 476 to encircle center drive rod assembly 236.In this way, rotation of knob 472 results in a transmission of arotational force to center drive rod assembly 236 via piston 478,wishbone link 476 and collar 474.

Turning now to FIGS. 58-62, a tip rotation assembly according to anotherembodiment of the present disclosure, for use with stitching device 100,is generally designated as 570. Tip rotation assembly 570 includes arotation knob 572 supported on housing 502. Knob 572 defines an innerhelical thread 572 a formed in an inner surface thereof: Tip rotationassembly 570 includes a nut disposed within housing 502. Nut 574includes a pair of opposed stems 574 a extending radially therefrom andthrough respective longitudinally extending slots 502 a formed inhousing 502. Stems 574 a of nut 574 are sufficiently long to engagehelical thread 574 a of rotation knob 574. Nut 574 defines an innerhelical thread 574 b.

Tip rotation assembly 570 further includes a lead screw 576 keyed to orotherwise connected to center drive rod assembly 236. Lead screw 576includes an outer thread or the like 576 a which is configured tooperatively engage inner helical thread 574 b of nut 574. Lead screw 576is further axially fixed and rotatably supported in braces 502 b formedin housing 502.

In operation, as seen in FIG. 62, as rotation knob 572 is rotated, stems574 a of nut 574 are engaged by the inner helical thread 572 a ofrotation knob 572 and cause nut 574 to move axially through housing 502and elongate slots 502 a of housing 502. As nut 574 moves axially thoughslots 502 a of housing 502, inner thread 574 a thereof engages thread576 a of lead screw 576 causing lead screw 576 to rotate since leadscrew 576 is axially fixed in braces 502 b of housing 502. As lead screw576 rotates, lead screw 576 transmits said rotation to center drive rodassembly 236.

Referring now to FIGS. 63-69, it is contemplated that each articulationcable 340, 342 may be operably associated with an arched seal 10disposed in mechanical cooperation with center drive rod assembly 236.Arched seal 10 includes a plurality of cable lumens 12 a-12 d (see 40FIG. 65) disposed around a center drive rod lumen 14, all extendingtherethrough. Center drive rod lumen 14 is configured to receive centerdrive rod assembly 236 therethrough. Each cable lumen 12 a-12 d isconfigured to receive one or more articulation cables 340, 342 insubstantial sealing relationship therewith. Each cable lumen 12 a-12 dmay have a respective arched section 16 that includes a venturi portion16 a configured to engage a surface of one or more articulation cables340, 342 so that arched seal 10 may move with articulation cables 340,342.

Venturi portion 16 a of each arched section 16 enables each cable lumen12 a-12 d to be repositionable through a plurality of positionsincluding a first position corresponding to a linear orientation of neckassembly 210 (e.g., FIG. 66) and a second position corresponding to anarticulated orientation of neck assembly 210 (e.g., FIG. 68) in responseto longitudinal translation of one or more articulation cables 340, 342therethrough. In this manner, the sealing relationship between archedseal 10 and articulation cables 340, 342 is maintained at all times whenneck assembly 210 is in either the linear or the articulatedorientation.

Turning now to FIGS. 70-72, a tip rotation assembly according to anotherembodiment of the present disclosure, for use with stitching device 100,is generally designated as 670. Tip rotation assembly 670 includes arotation knob 672 supported on housing 302 (see FIG. 70) and a beveledgear assembly 680 operatively associated with rotation knob 672. Beveledgear assembly 680 includes a sun gear 682 disposed in mechanicalcooperation with knob 672, a first beveled gear 684 that is operativelyassociated with sun gear 682, and a second beveled gear 686 operativelyassociated with first beveled gear 684. First beveled gear 684 may begenerally orthogonally disposed relative to sun gear 682 and secondbeveled gear 686. Second beveled gear 686 is disposed in mechanicalcooperation with center drive rod assembly 236 for facilitating thetransfer of rotational energy from tip rotation assembly 670 to centerdrive rod assembly 236 for opening and closing jaws 230, 232.

Tip rotation assembly 670 further includes a first beveled gear mount685 disposed in mechanical cooperation with first beveled gear 684 andknob 672. First beveled gear mount 685 rotatably supports first beveledgear 684 relative to knob 672 and, in particular, interconnecting sungear 682 and second beveled gear 606.

Sun gear 682 and second beveled gear 686 may be configured anddimensioned to rotate about the longitudinal axis of the stitchingdevice 100 in offset relationship relative to each other. First beveledgear mount 685 is configured to orient first beveled gear 684 such thatfirst beveled gear 684 rotates about an axis transverse to thelongitudinal axis of the stitching device 100. Second beveled gear 686may be keyed to or flat surfaces for engaging center drive rod assembly236 while still allowing axial movement of center drive rod assembly 236relative to second beveled gear 686. Sun gear 682, first beveled gear684, and second beveled gear 686 may be configured and dimensioned tocollectively allow only minimal (e.g., five degrees) rotationalbacklash. In addition, beveled gear assembly 680 of tip rotationassembly 670 may be configured and dimensioned to translate rotationalenergy to the center drive rod assembly 236 in accordance with one ormore of the following ratios: 1:1, more than 1:1, or less than 1:1.

In operation, as rotation knob 672 is rotated (may be clockwise orcounterclockwise) about the longitudinal axis of the stitching device100, sun gear 682 (keyed to rotation knob 672) of beveled gear assembly680 concentrically rotates therewith. Sun gear 682 engages with a firstgear portion 684 a of first beveled gear 684, causing first beveled gear684 to be rotated about an axis transverse to the longitudinal axis ofthe stitching device 100. Rotation of the first beveled gear 684 causessecond gear portion 684 b of first beveled gear 684 to engage secondbeveled gear 686 and to rotate second beveled gear 686 about thelongitudinal axis of the stitching device 100. Rotation of the secondbeveled gear 686 causes the center drive rod assembly 236 to rotate andthus cause jaws 230, 232 to rotate.

Referring now to FIGS. 73-78, a handle assembly 1300 including anotherembodiment of an articulation assembly 1000 is shown. Articulationassembly 1000 includes an articulation cam 1010, a first pin 1020, asecond pin 1030, a first slider 1040, a second slider 1050, and firstand second articulation cables 340, 342. Articulation cam 1010 includesfirst and second articulation arms 1012, 1014, and first and second camdisks 1016, 1018 for positioning articulation cam 1010 through aplurality of positions corresponding to a linear and/or angularorientation of neck assembly 210 including a first position (FIG. 76), asecond position (FIG. 77), and a third position (FIG. 78).

Articulation cam 1010 is supported in a housing 1302 of handle assembly1300. First and second cam disks I 016, I 018 define opposing respectivefirst and second camming channels 1016 a, 1018 a therein. First andsecond camming channels 1016 a, 1018 a may have a shape substantiallysimilar to a logarithmic spiral that may be configured to provideequidistant linear motion directly proportional to the angular rotationof first and second cam disks 1016, 1018. As such, each articulationcable 340, 342 may remain substantially taut upon translation thereofrelative to housing 1302.

Referring again to FIGS. 73-78, first pin 1020 is operably associatedwith first camming channel 1016 a of first cam disk 1016 and with firstslider 1040. First slider 1040 is configured to longitudinally translatein a channel defined in housing 1302. Second pin 1030 is operablyassociated with second camming channel 1018 a of second cam disk 1018and with second slider 1050. Second slider 1050 is configured tolongitudinally translate in a channel defined in housing 1302. First andsecond sliders 1040, 1050 are secured to respective proximal ends offirst and second articulation cables 340, 342. Distal ends of first andsecond articulation cables 340, 342 are secured at a location distal ofthe neck assembly 210, as described above. Articulation cables 340, 342are disposed on opposed sides of center drive rod assembly 236.

In operation, to articulate neck assembly 210, articulation cam 1010 isrotated via first and/or second articulation arms 1012, 1014. As seen inFIGS. 73-78, as articulation cam 1010, is rotated, first and second pins1020, 1030 translate through respective first and second cammingchannels 1016 a, 1018 a of first and second cam disks 1016, 1018, andcause respective first and second sliders 1040, 1050 to longitudinallytranslate. As first and second sliders 1040, 1050 longitudinallytranslate, either first or second articulation cables 340, 342 retract,depending on the direction of the rotation of the articulation cam 1010,thereby causing neck assembly 210 to articulate. In this manner, onearticulation cable 340, 342 is retracted, while the other articulationcable 340, 342 extends precisely the same length as the other shortens.The retraction and extension of the articulation cables 340, 342 areproportional with the curvature of first and second camming channels1016 a, 1018 a of first and second cam disks 1016, 1018.

In other words, upon articulation of neck assembly 210, the articulationcable 340, 342 translating in a distal direction must travel a greaterdistance as compared to articulation cable 340, 342 translating in aproximal direction. As such, in order to compensate for any slack in thetension of articulation cables 340, 342, first and second cammingchannels 1016 a, 1018 a have been shaped to cause greater proximaltranslation of articulation cable 340 or 342 the greater the degree ofrotation of first and/or second actuation arms 1012,1014.

First and second cam disks 1016, 1018 may be monolithically formed. Asillustrated in another embodiment of an articulation cam designatedgenerally as 2010 and shown in FIG. 79, first and second cam disks 2016,2018 may be separate and distinct such that each may rotate in opposedrotational directions via first and second articulation arms 2012, 2014.A torsion spring 2015 may operably couple first and second cam disks2016, 2018 such that distal and proximal ends of torsion spring 2015 aredisposed in mechanical cooperation with respective first and second camdisks 2016, 2018. Torsion spring 2015 may be supported on a shaftaxially disposed between first and second cam disks 2016, 2018 tofacilitate about 10 to 15 degree rotation of each cam disk 2016, 2018 inrelation to each other. Torsion spring 2015 may be preloaded such thatit generates force sufficient for maintaining articulation cables 340,342 in tension for precision operation of the stitching device I 00. yetconfigured to limit rotation of first and second cam disks 2016, 2018relative to each other during articulation of the neck assembly 210.

As illustrated in other embodiments of articulation assemblies 3000,4000, 5000 shown in FIGS. 80-82, articulation cables 340, 342 may beattached directly to first or second pins 1020, 1030 that are disposedin mechanical cooperation with respective first and second cam disks1016, 1018, 2016, 2018 for providing longitudinal translation. Asillustrated in the embodiments shown in FIGS. 80-81, articulation cables340, 342 may be redirected by one or more rollers “R” mounted at variouspositions on housing 302, 1302. As such, first and second cam disks1016, 1018, 2016, 2018 may be positioned in longitudinal alignment withthe longitudinal axis of the stitching device, transverse thereto, orany other variation thereof since rollers “R” may redirect thearticulation cables 340, 342 in any direction, depending on placementthereof.

Turning now to FIGS. 83-88, an alternate embodiment of a neck assemblyis generally designated as 1210. Neck assembly 1210 is similar to neckassembly 210 and thus will only be discussed herein to the extentnecessary to identify differences in construction and operation thereof.

As seen in FIGS. 83-88, each link 212 defines a pair of opposedstiffener plate receiving slots 216 a, 216 b. Slots 216 a, 216 b arefanned on either side of central lumen 212 c and are interposed betweencentral lumen 212 c and a respective articulation cable lumen 212 e 1,212 e 2. As shown in FIGS. 83 and 88, neck assembly 1210 includes a pairof stiffener plates 218 a, 218 b translatably disposed in the platereceiving slots 216 a, 216 b, respectively. As seen in FIG. 87, adistal-end of each stiffener plate 218 a, 218 b includes an anchorportion 219 to securely attach respective distal-end of stiffener plate218 a, 218 b to stem 212 f of neck assembly 1210, while allowing theproximal-end of each stiffener plate 218, 218 b to translate freelythrough plate receiving slots 216 a, 216 b.

In an embodiment, as seen in FIG. 87, anchor portion 219 of eachstiffener plate 218 a, 218 b may be bifurcated and include a pair ofspaced apart tines that snap-fit into packets formed at the ends ofplate receiving slots 216 a, 216 b. Each stiffener plate 218 a, 218 bmay have an elongated, flattered (e.g., ribbon-like) profile. Eachstiffener plate 218 a, 218 b thus defines a plane, wherein the stiffenerplates 218 a, 218 b are supported in neck assembly 1210 such that therespective planes of stiffener plates 218 a, 218 b arc substantiallyparallel with one another. In the present embodiment, the planes ofstiffener plates 218 a, 218 b are oriented substantially orthogonal to adirection of articulation of end effector 200. Stiffener plates 218 a,218 b may be constructed from any durable resilient material, such as,for example, stainless steel, titanium, etc.

Links 212 are configured to enable end effector 200 to move between asubstantially linear configuration and a substantially angled, off-axisor articulated configuration. Since stiffener plates 218 a, 218 b areoriented such that the planes thereof are substantially orthogonal to adirection of articulation of end effector 200, movement or articulationof end effector 200 is restricted solely in two dimensions (i.e., asingle plane). As illustrated in FIG. 87, stiffener plate 218 a (andstiffener plate 218 b, not shown) restrict(s) movement or canting of endeffector 200 in the direction of arrows “A.”

Turning now to FIG. 89, an alternate embodiment of a drive assembly isgenerally designated as 2240. Drive assembly 2240 is similar to driveassembly 240 and thus will only be discussed herein to the extentnecessary to identify differences in construction and operation thereof.As seen in FIG. 89, drive assembly 2240 includes an inner drive member2242 and an outer drive member 2244. Inner drive member 2242 includes apartially circular collar 2242 a and a first blade 2250 b extendingtherefrom. First blade 2250 b and the partially circular collar 2242 aare constructed or stamped as one unitary member from one piece of sheetmetal. Similarly, outer drive member 2244 includes a partially circularcollar 2244 a and a second blade 2252 b extending therefrom. Secondblade 2252 b and the partially circular collar 2244 a are alsoconstructed or stamped as one unitary member from one piece of sheetmetal. The partially circular collar 2242 a of inner drive member 2242is nested within the partially circular collar 2244 a of outer drivemember 2244 and defines a lumen 2242 b through which center drive roddistal portion 236 a of center drive rod assembly 236 is received. Innerand outer drive members 2242, 2244 provide a snap feature that snapsaround inner and outer bushings (not shown), thereby allowing rotationof inner and outer drive members 2242, 2244 around the inner and outerbushings, respectively. Such design reduces the number of parts that arerequired to hold blades 2250 b, 2252 b m place, thereby simplifyingmanufacturability and reducing cost of manufacturing.

While the disclosure has been particularly shown and described withreference to particular embodiments, it will be understood by thoseskilled in the art that various modifications in form and detail may bemade therein without departing from the scope and spirit of theinvention. Accordingly, modifications such as those suggested above, butnot limited thereto, are to be considered within the scope of theinvention.

What is claimed is:
 1. An endoscopic stitching device, comprising: anelongate shaft; an end effector supported on a distal end of theelongate shaft, the end effector including: a neck assembly configuredfor articulation between a substantially linear configuration and anoff-axis configuration, the neck assembly including a plurality of linksin pivotable contact with one another; and a pair of jaws operativelycoupled with the neck assembly; and a stiffener plate extending throughat least a pair of the plurality of links, wherein the stiffener plateincludes proximal and distal ends, wherein of the proximal and distalends of the stiffener plate only the distal end is affixed to theendoscopic stitching device.
 2. The endoscopic stitching deviceaccording to claim 1, wherein the pair of jaws is rotatably supported onthe end effector for selective rotation about a longitudinal axisthereof.
 3. The endoscopic stitching device according to claim 1,wherein each link of the plurality of links includes a knuckle formed ona first side thereof and a clevis formed on a second side thereof,wherein the knuckle of a first link of the plurality of links isoperatively connected to the clevis of an adjacent link.
 4. Theendoscopic stitching device according to claim 3, wherein the knucklesand devises are configured to enable articulation of the neck assemblyin a single plane.
 5. An endoscopic stitching device, comprising: an endeffector including: a neck assembly configured for articulation betweena substantially linear configuration and an off-axis configuration; anda pair of jaws coupled to the neck assembly, each jaw of the pair ofjaws movable relative to the other jaw; and a stiffener plate disposedin the neck assembly and axially extending therein, wherein thestiffener plate inhibits canting of the end effector in a directionorthogonal to a direction of articulation of the end effector, whereinthe stiffener plate includes a detached proximal end and a distal end,wherein of the detached proximal end and the distal end of the stiffenerplate only the distal end of the stiffener plate is secured with the endeffector.
 6. The endoscopic stitching device according to claim 5,wherein the stiffener plate defines a plane that is substantiallyorthogonal to the direction of articulation of the end effector.
 7. Theendoscopic stitching device according to claim 6, wherein the stiffenerplate is substantially flat and is bendable in a first direction.
 8. Theendoscopic stitching device according to claim 6, wherein the directionof articulation of the end effector is out of the plane defined by thestiffener plate.
 9. The endoscopic stitching device according to claim6, wherein the stiffener plate restricts articulation of the endeffector in the plane defined by the stiffener plate.
 10. The endoscopicstitching device according to claim 6, wherein the neck assembly furtherincludes a plurality of links in pivotable contact with one another,wherein each link defines a stiffener plate receiving slot for receivingthe stiffener plate therethrough.
 11. The endoscopic stitching deviceaccording to claim 6, wherein the distal end of the stiffener plateincludes an anchor portion secured with the end effector.
 12. Theendoscopic stitching device according to claim 11, wherein the anchorportion is bifurcated and includes at least a pair of spaced aparttines.
 13. The endoscopic stitching device according to claim 12,wherein each jaw of the pair of jaws defines a suture needle receivingrecess formed in a tissue contacting surface thereof.
 14. The endoscopicstitching device according to claim 6, wherein the stiffener plate ismade of resilient material.
 15. An endoscopic stitching device,comprising: a handle assembly; an elongate shaft supported by andextending from the handle assembly; an end effector supported on adistal end of the elongate shaft, the end effector including: a neckassembly configured for articulation between a substantially linearconfiguration and an off-axis configuration; and a pair of jawsoperatively coupled with the handle assembly, each jaw of the pair ofjaws pivotally associated with the other jaw; and a pair of stiffenerplates disposed in the neck assembly and axially extending therein,wherein each stiffener plate of the pair of stiffener plates defines aplane and includes a proximal end and a distal end, wherein of theproximal and distal ends of the respective stiffener plates only thedistal ends of the respective stiffener plates are secured withinrespective slots defined in the end effector, the slots dimensioned toreceive the respective stiffener plates, the proximal ends of therespective stiffener plates being detached from the endoscopic stitchingdevice.
 16. The endoscopic stitching device according to claim 15,wherein the stiffener plates are disposed substantially parallel withone another.
 17. The endoscopic stitching device according to claim 16,wherein the end effector is articulatable in a direction out of theplane defined by a respective one stiffener plate of the pair ofstiffener plates.
 18. The endoscopic stitching device according to claim15, wherein the plane defined by each stiffener plate of the pair ofstiffener plates is substantially orthogonal to the direction ofarticulation.
 19. The endoscopic stitching device according to claim 15,wherein each stiffener plate of the pair of stiffener plates issubstantially flat.